البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Wuhan Zonsen Medical Products Co., Ltd.
TOPICAL
OTC DRUG
- Healthcare antiseptic for preparation of the skin prior to surgery. - First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
OTC monograph not final
ZONSEN POVIDONE-IODINE PREP PAD- POVIDONE-IODINE SWAB WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- ZONSEN POVIDONE-IODINE PREP PAD _DRUG FACTS_ _ACTIVE INGREDIENTS_ Povidone-Iodine 10% w/w (1% available iodine) _PURPOSE_ Antiseptic _USE_ Healthcare antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns. _WARNINGS_ For external use only. DO NOT USE in the eyes. longer than 1 week unless directed by a doctor. on individuals who are allergic or sensitive to iodine. or apply over large areas of the body. STOP USE AND ASK A DOCTOR IF If irritation and redness develop. condition persist for more than 72 hours. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ Clean the affected area. For preparation of the skin prior to surgery: apply product to the operative site prior to surgery For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first. _INACTIVE INGREDIENTS:_ Sodium hydroxide, water _OTHER INFORMATION_ Protect from freezing Avoid excessive heat. PACKAGE LABELING: ZONSEN POVIDONE-IODINE PREP PAD povidone-iodine swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:729 32-0 0 3 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4) IODINE 10 0 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING STA اقرأ الوثيقة كاملة